Details for New Drug Application (NDA): 021825
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NDA 021825 describes FERRIPROX, which is a drug marketed by Chiesi and is included in three NDAs. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FERRIPROX profile page.
The generic ingredient in FERRIPROX is deferiprone. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
The generic ingredient in FERRIPROX is deferiprone. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
Summary for 021825
| Tradename: | FERRIPROX |
| Applicant: | Chiesi |
| Ingredient: | deferiprone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021825
| Mechanism of Action | Iron Chelating Activity |
Suppliers and Packaging for NDA: 021825
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FERRIPROX | deferiprone | TABLET;ORAL | 021825 | NDA | Chiesi USA, Inc. | 10122-100 | 10122-100-10 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-100-10) |
| FERRIPROX | deferiprone | TABLET;ORAL | 021825 | NDA | Chiesi USA, Inc. | 10122-103 | 10122-103-05 | 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-103-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Oct 14, 2011 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Apr 30, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS | ||||||||
| Regulatory Exclusivity Expiration: | Apr 30, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS | ||||||||
| Regulatory Exclusivity Expiration: | Apr 30, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT PATIENTS WITH THALASSEMIA SYNDROMES EXCLUDING ADULT PATIENTS COVERED BY THE INDICATION FOR THALASSEMIA SYNDROMES APPROVED ON OCTOBER 14, 2011 | ||||||||
Expired US Patents for NDA 021825
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 021825-002 | Jul 25, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 021825-001 | Oct 14, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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